1. Field of the Invention
The present invention relates generally to a pill having a radio frequency tag associated therewith that allows for monitoring patient medicine intake compliance and determining an identity of the pill and quantity thereof ingested by an individual.
2. Description of the Related Art
Despite the life-saving benefits of many prescription medications, only 30%-70% of patients adhere to the prescribed intake of their medications, and less than 50% reliably adhere to long-term prescriptions. Medication non-adherence affects the healthcare industry at both a patient level and at a pharmaceutical corporate level. Patients are deprived of the benefits of the medications, which can result in increased hospitalizations and mortality. It has been estimated that medication non-adherence accounts for 11% of all hospitalizations for the elderly, with more significant consequences in sub-groups of patients with severe illnesses such as heart failure where 24%-43% of all hospital admissions have been attributed to medication non-adherence. Non-adherence also has financial consequences to pharmaceutical companies due to lost revenue. It has been estimated that the yearly loss of revenue for cholesterol lowering medications due to non-adherence is $3.9 billion with close to $70 billion lost for all drug classes.
Identification of patients who do not adhere to medical therapy is challenging because patients underestimate the frequency with which they fail to take medications. Although some drugs can be detected by diagnostic serum or urine assays, such tests are not a feasible way of monitoring long-term adherence because few medications can be detected with existing tests and the cost and logistics of routinely performing such tests would be prohibitive. Specifically, although a chemical agent may be added to pills which could be detected for adherence, there are several significant problems with this approach. First, a large number of additives would need to be identified given the thousands of prescription medications currently available. Second, these agents would need to be absorbed and detected in blood or urine analysis, or if not absorbed, then be detected in feces. Absorbed chemicals would have to undergo extensive regulatory review to be deemed safe, and then the levels of the chemicals would need to be correlated with liver and kidney dysfunction, which are common in people taking medications. Collection of non-absorbed chemicals or markers would also be challenging. Even if a suitable number of unique, well-absorbed, biologically inert chemicals were identified, in-vivo detection would be logistically difficult and expensive. It is unlikely that a patient who proves to be non-adherent with taking pills would be more compliant with regularly scheduled blood or urine analysis.
Because most medications are in the form of a pill, monitoring of medication decanting may be used to monitor compliance. Specifically, electronic Medication Event Monitoring Systems (MEMS) have been used in studies to assess medication compliance, and in several instances have been used as an adjunct to outpatient monitoring in an effort to improve medication compliance. For example, U.S Pat. Publication No. US 2004/0008123 to Carrender et al. discloses a sensing device integrated into a pill container to sense the opening thereof. Similarly, U.S. Pat. No. 5,016,172 to Dessertine discloses a patient compliance and status monitoring system that utilizes a cap-opening counting device to record the number of cap openings. A further example is disclosed in U.S Pat. Publication No. 2003/0009088 to Korth et. al wherein a pill dispenser is equipped with a transmitter configured to transmit a message that a drug has been removed from the dispenser. However, as is evident in the prior art, MEMS devices only record the number of times a bottle was opened, and not how many, if any, pills were removed or what pharmaceutical content was contained in those pills. Additionally, MEMS devices have been found to be. incompatible with complex medical regimens and frequently interfere with personal adherence strategies. Finally, widespread implementation of MEMS devices would require significant logistical support at a pharmacy/pharmacist level.
Due to patients not accurately reporting medication adherence and the fact that monitoring of adherence at the level of the medication dispensing container is unlikely to be feasible, it is increasingly clear that other forms of medication adherence may be appropriate. It is, therefore, desirable to overcome the above problems and others by providing a system and method for quickly, efficiently and accurately qualifying and quantifying patient medication to not only monitor patient medicine intake compliance, but also to determine an identity of any pills and quantity thereof ingested by an individual.